N/A
N=19
Effects of Audiovisual Distraction on Desaturation and Airway Intervention in OSA-patients
Obstructive Sleep Apnea (OSA)
Bottom Line
View on ClinicalTrials.gov: NCT03020914 ↗Enrolled (actual)
19
Serious AEs
—
Results posted
May 2022
Primary outcome: Primary: Desaturations — 0; 1 number of desaturation events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Audiovisual Distraction (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Desaturations |
0; 1 | — |
| SECONDARY Airway Interventions |
2; 7 | — |
| SECONDARY Additional Sedation |
2; 1 | — |
| SECONDARY Patient Satisfaction |
55; 54 | — |
| SECONDARY Alertness Levels |
0; 0 | — |
Summary
Patients will be randomly assigned to either one of two groups:
1. Standard of care sedation
2. Audiovisual distraction during surgery and in the recovery room using video goggles and headphones; patients can choose a movie from a preexisting library
Monitoring and anesthesia regimen will be standardized
Eligibility Criteria
Inclusion Criteria
- Patients with known OSA (preexisting diagnosis of obstructive sleep apnea (OSA) or patients with a STOP BANG Score of 5 or above) undergoing primary total knee arthroplasty under neuraxial anesthesia
Exclusion Criteria
- Contraindications to neuraxial anesthesia or allergy to study medication
- Patients with audiovisual impairments prohibiting them from proper use of the study device:
- Patients who are blind
- Patients with hearing aids
- Age <18 years
- Patients with inability to communicate in English or understand the study requirements
- Patients with prior history of claustrophobia
- Patients with prior history of epilepsy or seizure disorder
- Patients undergoing a revision
Data sourced from ClinicalTrials.gov (NCT03020914). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.